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OpenTrials
Completed

NCT Number: NCT03312816

Effect of Oxidized Plant Sterols on Serum Concentrations of Plant Sterol Oxidation Products (POP)

The study is a randomised, double-blind, placebocontrolled, parallel dose-response study with four study arms. Sixty subjects will be randomly allocated to consume study products containing varying amounts of plant sterol (PS) oxidation products (POP) or placebo for 6 weeks.

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Key information

Conditions

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Research Organisation GmbH

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Apparently healthy men and women as judged by study physician.
  • BMI > 18 and < 35 kg/m2.
  • Total cholesterol levels at screening ≥5.0 and ≤8.0 mmol/L
  • Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by the study physician.

Exclusion criteria

  • Recently (<6 months) diagnosed with cardiovascular event(s) (stroke, TIA (Transient ischemic attack), angina, myocardial infarction, heart failure), revascularization or systemic inflammatory conditions.
  • Use of plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study.
  • Use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. statins, ezetimibe, fibrates, diabetic drugs, angiotensin receptor blockers (ARB) and ACE (Angiotensin-converting enzyme) inhibitors)), to be judged by the principal investigator.
  • Use of oral antibiotics (with the exception of topical antibiotics) in 40 days or less prior to Day -2.
  • Pregnant or lactating women.
  • Reported alcohol consumption > 14 units/week (female) or > 21 units/week (male).
  • Reported intense sporting activities > 10 hours/week.
  • Reported weight loss or gain of 3 kg or more during a period of 6 months prior to screening.
  • Currently on a medically- or self-prescribed diet, or slimming diet, or the intention to use any kind of diet during the study.
  • Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.

Treatment and study plan

cookies enriched with POP

Other

Cookies

Primary outcomes

  1. POP (plant sterol oxidation products) value

    Time frame: 0 to 42 days

    To estimate the change from baseline in serum POP concentration after intake of various POP doses.

Secondary outcomes

  1. COP (cholesterol oxidation products) value

    Time frame: 0 to 42 days

    To estimate the change from baseline in serum COP concentrations after intake of various POP doses.

  2. Ratio of serum POP concentration

    Time frame: 0 to 42 days

    To estimate the ratio of serum POP concentrations vs. COP concentrations after intake of various POP doses.

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Official study title

The Effect of Oxidized Plant Sterol Intake on Serum Concentrations of Plant Sterol Oxidation Products (POP)

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 18, 2017
Registry last updated
Jun 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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